EN   EN  
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2020) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Annex II to Regulation (EU) 2018/848 of the European Parliament and of the 
Council as regards organic production rules on sprouted seeds and chicory heads, on 
feed for certain aquaculture animals and on aquaculture parasite treatments  
(Text with E EA relevance)  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the Commission.  
  
EN 2  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
Following the adoption of the R egulation (EU) 2018/848, it is necessary to adopt this 
Delegated Regulation as regards certain provisions concerning sprouted seeds  and chicory 
heads and aquaculture animal species. In particular, on sprouted seeds and chicory heads 
several stakeholders required clarification wi th respect to the terminology and the growing 
media allowed in organic production, hence it is necessary to amend the current provisions to 
increase legal certainty.  
As regards aquaculture animal  species, it is necessary to reflect the current possibility to use 
organic cholestero l for shrimps and prawns and to amend provisions concerning parasite 
treatments  aquaculture animals based on the recent conclusions of the Expert group for 
technical  advice on Organic production1. 
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
The act was thoroughly discussed with Member States at the Group of Experts on Organic 
Production as well as with the main organisations representing the organic sector, namely 
IFOAM and their sector specific affiliated groups, COPA -COGECA and FEAP. DG AGRI 
cooperated closely with DG MARE and other DGs  in the field of their specific expertise when 
drafting these rules, in particular with DG SANTE. WTO partners were notified and general 
public consultations were carried out. ( to add late r feedback)  
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
Regulation (EU) No 2018/848 underlines in its recital 29 that certain cultivation practices not 
soil-related such as production of sprouted seeds or chicory heads should be allowed and the 
Commission is em powered under Article 12 of Regulation (EU) 2018/848 to amend the 
current provisions for derogation on sprouted seeds and chicory heads laid down by point 1.3 
of Part I of Annex II to R egulation (EU) 2018/848.  
Moreover, recital 50 of Regulation (EU) 2018/848 states that to ensure quality, traceability, 
compliance with this Regulation and adaptation to technical developments, the power to adopt 
certain acts is delegated to the Commission in respect of feed for aquaculture animals and th e 
veterinary treatments of those animals and in respect of detailed conditions for broodstock 
management, breeding and juvenile production.  
This delegated act amends certain current provisions concerning sprouted seeds and chicory 
heads to increase legal certainty . As regards nutritional supplement  and veterinary treatments  
for aquaculture animals, they concern su pplement of cholesterol for paeneid shrimps and 
freshwater prawns  and to parasite treatment s, introducing a species -specific approach in line 
with principles of the animal welfare.  
                                                 
1 EGTOP Final report on Aquaculture IV – 13 December 2019  .  
EN 3  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Annex II to Regulation (EU) 2018/848 of the European Parliament and of the 
Council as regards organic production rules on sprouted seeds and chicory heads, on 
feed for certain aquaculture animals and on aquaculture parasite treatments  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European U nion, 
Having regard to Regulation (EU) 2018/848 of the European Parliament and of the Council of 
30 May 2018 on organic production and labelling of organic products and repealing Council 
Regulation (EC) No 834/20072, and in particular Article 12 (2)(a) and Article 15 (2)(b) and (c) 
thereof,  
Whereas:  
(1) Commission Delegated Regulation (EU) 2020/4273 has recently amended point 1.3 of 
Part I of Annex II to Regulation (EU) 2018/848 with respect to organic sprouted seeds 
to ensure their production from organic seeds. G iven that sprouted seeds include 
sprouts, shoots and cress4, which can use exclusively the reserves in the seeds to 
sprout, only water should be used for organic production. Therefore, it needs to be  
clarifie d that the derogation from soil -related cultivation for sprouted seeds is limited 
to moistening seeds  and it should be stated explicitly that the use of a growing medium 
is not allowed, except the use of an inert medium t o keep the  seeds moist  when the 
components of that inert medium are authorised  in compliance with Article 24 of 
Regulation (EU) 2018/848.  
(2) With respect to chicory heads, their specific production cycle can consist of two 
phases one in soil and one called “forcing phase” , which can be in soil, but also in 
water or substrates. Therefore, it is necessary to clarify that the derogation from soil 
related cultivation for chicory heads includes deepening in clear w ater and that the use 
of a growing medium is allowed only when its components are authorised in 
compliance with  Article 24 of Regulation (EU) 2018/848.  
                                                 
2 Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic 
production and labelling of  organic products and repealing Council Regulation (EC) No 834/2007, OJ L 
150, 14.6.2018, p. 1 –92. 
3 Commission Delegated Regulation (EU) 2020/427 of 13 January 2020 amending Annex II to 
Regulation (EU) 2018/848 of the European Parliament and of the Council as regards certain detailed 
production rules for organic products (OJ L 87, 23.3.2020, p. 1). 
4 Descriptio n of their production cycles in EFSA Scientific Opinion on the  risk posed by Shiga toxin-
producing Escherichia coli (STEC) and other pathogenic bacteria in seeds and sprouted seeds – EFSA 
Journal 2011; 9(11):2424. [101 pp]  doi:10.2903/j.efsa.2011.2424.     
EN 4  EN (3) Article 25l(3)(b) of Commission Regulation (EC) No 889/20085 allowed organic 
cholesterol to be used to supplement natural feed in the grow -out stage and earlier life 
stages of penaeid shrimps and freshwater prawns ( Macrobrachium spp.). It is therefore 
necessary to provide for the supplementation of feed with organic cholesterol to those 
shrimps a nd prawns in  point 3.1.3.4 of Part III of Annex II to Regulation (EU) 
2018/848. 
(4) In 2019, when discussing the draft of Delegated Regulation (EU) 2020/427, some  
Member States requested the revision of other rules relating to organic aquaculture. 
The expert group for t echnical advice on organic production (EGTOP) set up by 
Commission Decision 2017/C 287/036 assessed those requests. Taking into account 
the EGTOP’s conclusions published7 in January 2020, the Commission has identified 
a need to update the existing production rules for aquaculture animals in particular 
with respect to veterinary treatments .  
(5) Notwithstanding the requirements  related to the prevention of diseases, such as the 
recommendation f or biological control of parasites with preference to be given to the 
use of cleaner fish and of freshwater, marine water and sodium chloride solutions, a 
limited number of treatments , in case of sev ere parasites occurrence , is currently 
allowed on a gener al basis for all species. Based on the above -mentioned EGTOP 
conclusions, it is appropriate to amend the current provisions on parasite treatments set 
out in point 3.1.4.2. of Part III of Annex II to Regulation (EU) 2018/848 by 
introducing a more species -specific  approach t o better address the needs of 
aquaculture animals without compromising the organic nature of the production.  
(6) In particular, in view of the variable  duration of the production cycle of species, other 
than salmon, and of the potential occurrence of parasites in the juvenile phase, together 
with the tendency of operators to postpone as far as possible any course s of treatment  
due to the frequency limit, in the first year of the life cycle, a high mortality rate of fry 
and juvenile s has been reported. Therefore, for other species than salmon, it is 
appropriate to align the frequency and maximum number o f parasite treatments with 
the frequency  limits set for other chemically synthes ised allopathic  veterinary 
medicinal products to permit to intervene when it is really necessary and  to avoid high 
mortality in the first stages of the life  cycle.  
(7) As regards salmon , considering the duration of the production cycle and the need to 
guarantee the non- occurrence of sea lice within the period in f reshwater, the current 
frequency limits and maximum number of courses  for parasite treatments should be 
maintained .  
(8) Moreover , it is important to clarify the current provisions, by setting a clear overall 
limit for the maximum number of parasite treatments that may be administered , 
regardless of the species concerned . 
(9) Annex II to Regulation (EU) 2018/848 should therefore be amended accordingly.  
(10) In the interest of clarity and legal certainty, this Regulation should apply from the date 
of applicatio n of Regulation (EU) 2018/848, 
                                                 
5 Commission Regulation (EC) No 889/2008 of 5 September 2008 l aying down detailed rules for the 
implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of 
organic products with regard to organic production, labelling and control  (OJ L 250 , 18.9.2008, p. 1) . 
6 Commission Decision of 30 August 2017 appointing the members of the group for technical advice on 
organic production and drawing up the pool list (OJ C 287, 30.08.2017, p. 3).  
7 EGTOP Final report on Aquaculture IV – 13 December 2019    
  
EN 5  EN HAS ADOPTED THIS REGULATION:  
Article 1  
Annex II to Regulation (EU) 2018/848 is amended in accordance with the Annex to this 
Regulation.  
Article  2 
This Regulation shall enter into force on the twentieth  day following that of its publication in 
the Official Journal of the European Union. 
It shall apply from 1 January 2022.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN